Unilateral Laparoscopic Adrenalectomy for Resistant Hypertension in Patients With Adrenal Diseases

NCT ID: NCT03535532

Last Updated: 2018-05-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-20
• Study Completion Date: 2021-12-20

Brief Summary

ULARH is a 2-arm, prospective, open-labeled, multi-center randomized clinical trial.The purpose of this study is to compare the effectiveness of medical treatment and unilateral laparoscopic adrenalectomy for resistant hypertension in patients diagnosed with adrenal disease based on imaging tools.Relative ratio of end-point events occurence in three years is considered as primary outcome. Furthermore, we will exploit clinical factors which could indicate a favorable outcome in participants who accepted surgical treatment in this study.

Detailed Description

Resistant hypertension is a clinical condition characterized by the presence of BP values above the recommended limits of the reference values(BP>140/90 mmHg in hypertensive patients), despite the adherence to appropriate life style changes and to a drug therapy of at least three classes of drugs, one of which is represented by a diuretic, in adequate doses. Several small-sample studies suggest the prevalence of resistant hypertension is about 5-30% in Chinese population. Uncontrolled blood pressure elevation attributes to a higher incidence of stroke, heart failure, chronic renal disease, dementia and cardiovascular deaths. Improving the management of resistant hypertension is a constantly tricky problem in hypertension clinical practice.

Compared with patients whose blood pressure level are more easily to get controlled, patients diagnosed with resistant hypertension presented a higher risk of adrenal anomaly when screened by imaging tools. Current clinical practice guidance recommend unilateral laparoscopic adrenalectomy as a preferable treatment merely for adrenal incidentalomas with over hormone secreting like cortisol or aldosterone, or a high likelihood of malignance. Among patients who meet above surgery indication, the ratio of cure for hypertension varies from approximately 30 to 80%. However, in recent years, there are growing evidence showed that hypertensive patients diagnosed with adrenal disease based on imaging tools also gain much benefit from adrenalectomy even if there is no evidently abnormal hormone secretion. Last year, a prospective cohort study published on <Ann Intern Med> suggested that "nonfunctional" adrenal tumors associate with increased diabetes risk. These studies prompt a re-assessment of the classification of benign adrenal tumors as "non-functional"and their potential damage.

In a retrospective study conducted by our group in early period to evaluate the effect of surgery treatment in resistant hypertensive patients, we found one third of resistant hypertensive patients were cured as well as another one third get improved after unilateral laparoscopic adrenalectomy. Thus, we designed this study, expecting a further and more detailed perception of the relationship between resistant hypertension and adrenal anomaly.

Conditions

Resistant Hypertension; Adrenal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

unilateral laparoscopic adrenalectomy

subjects allocated in this group will be given unilateral laparoscopic adrenalectomy as treatment.

Group Type: EXPERIMENTAL

unilateral laparoscopic adrenalectomy

Intervention Type: PROCEDURE

unilateral laparoscopic adrenalectomy is a kind of minimally invasive surgery commonly operated in patients diagnosed with adrenal diseases with a high likelihood of malignance or surplus hormone secretion.

standard medical treatment

subjects allocated in standard medical treatment group will be given conservative medicine treatment.

Group Type: ACTIVE_COMPARATOR

standard medical treatment

Intervention Type: DRUG

standard medical treatment: detailed medicine strategy chosen for each patient will be associated with their own conditions based on current guidance recommendations.

Interventions

unilateral laparoscopic adrenalectomy

unilateral laparoscopic adrenalectomy is a kind of minimally invasive surgery commonly operated in patients diagnosed with adrenal diseases with a high likelihood of malignance or surplus hormone secretion.

Intervention Type: PROCEDURE

standard medical treatment

standard medical treatment: detailed medicine strategy chosen for each patient will be associated with their own conditions based on current guidance recommendations.

Intervention Type: DRUG

Other Intervention Names

standard medical treatment; unilateral laparoscopic adrenalectomy

Eligibility Criteria

Inclusion Criteria

1. Resistant hypertensive patients diagnosed with adrenal disease based on imaging tools (resistant hypertension defined as the presence of BP values above the recommended limits of the reference values(BP>140/90 mmHg),despite the adherence to appropriate life style changes and to a drug therapy of at least three classes of drugs for at least one month, one of which is represented by a diuretic, in adequate doses)

2. Signed the written informed consent.

Exclusion Criteria

1. Patients with surgical contraindication;(Performed coronary revascularization (PCI or CABG) within the previous 6 months; Cerebral hemorrhagic stroke within the previous 3 months, or new onset cerebral infarction within the latest 2 weeks;Severe heart failure or kidney disfunction within the previous 6 months)

2. Patients who has proceeded unilateral laparoscopic adrenalectomy once;

3. Severe somatic disease such as cancer;

4. Severe cognitive impairment or mental disorder;

5. Participating in other clinical trials.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jun Cai

Director, Hypertension Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Cai, MD

Role: STUDY_DIRECTOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

Chinese Academy of Medical Sciences, FuWai Hospital

Beijing, Beijing Municipality, China

Shandong Provincial Hospital

Ji'nan, Shandong, China

Yunzhou Municiple Hospital

Ji'ning, Shandong, China

Countries

China

Central Contacts

Weili Zhang, MD

Role: CONTACT

zhangweili1747@yahoo.com

861088322025

Yue Deng

Role: CONTACT

dy611381@163.com

861088322025

Facility Contacts

Jun Cai, MD

Role: primary

Weili Zhang

Role: backup

Shaobo Shaobo

Role: primary

Xinhai Wang

Role: primary

References

Sim JJ, Bhandari SK, Shi J, Reynolds K, Calhoun DA, Kalantar-Zadeh K, Jacobsen SJ. Comparative risk of renal, cardiovascular, and mortality outcomes in controlled, uncontrolled resistant, and nonresistant hypertension. Kidney Int. 2015 Sep;88(3):622-32. doi: 10.1038/ki.2015.142. Epub 2015 May 6.

Reference Type: BACKGROUND

PMID: 25945406 (View on PubMed)

Lopez D, Luque-Fernandez MA, Steele A, Adler GK, Turchin A, Vaidya A. "Nonfunctional" Adrenal Tumors and the Risk for Incident Diabetes and Cardiovascular Outcomes: A Cohort Study. Ann Intern Med. 2016 Oct 18;165(8):533-542. doi: 10.7326/M16-0547. Epub 2016 Aug 2.

Reference Type: BACKGROUND

PMID: 27479926 (View on PubMed)

Xu T, Xia L, Wang X, Zhang X, Zhong S, Qin L, Zhang X, Zhu Y, Shen Z. Effectiveness of partial adrenalectomy for concomitant hypertension in patients with nonfunctional adrenal adenoma. Int Urol Nephrol. 2015 Jan;47(1):59-67. doi: 10.1007/s11255-014-0841-8. Epub 2014 Oct 11.

Reference Type: BACKGROUND

PMID: 25305227 (View on PubMed)

Fassnacht M, Arlt W, Bancos I, Dralle H, Newell-Price J, Sahdev A, Tabarin A, Terzolo M, Tsagarakis S, Dekkers OM. Management of adrenal incidentalomas: European Society of Endocrinology Clinical Practice Guideline in collaboration with the European Network for the Study of Adrenal Tumors. Eur J Endocrinol. 2016 Aug;175(2):G1-G34. doi: 10.1530/EJE-16-0467.

Reference Type: BACKGROUND

PMID: 27390021 (View on PubMed)

Denolle T, Chamontin B, Doll G, Fauvel JP, Girerd X, Herpin D, Vaisse B, Villeneuve F, Halimi JM. [Management of resistant hypertension. Expert consensus statement from the French Society of Hypertension, an affiliate of the French Society of Cardiology]. Presse Med. 2014 Dec;43(12 Pt 1):1325-31. doi: 10.1016/j.lpm.2014.07.016. Epub 2014 Nov 20. French.

Reference Type: BACKGROUND

PMID: 25459067 (View on PubMed)

Other Identifiers

ULARH2017

Identifier Type: -

Identifier Source: org_study_id